510(k) K843506

LKB 2189 ULTROPROCESSOR by Lkb Instruments, Inc. — Product Code IEO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 30, 1984
Date Received
September 6, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Processor, Tissue, Automated
Device Class
Class I
Regulation Number
864.3875
Review Panel
PA
Submission Type